Status:
COMPLETED
Change in Quality of Life After Addition of Weekly 40 mg Pegvisomant/Placebo in Controlled Acromegalic Patients
Lead Sponsor:
Erasmus Medical Center
Conditions:
Quality of Life
Acromegaly
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Study Synopsis Study Title: Double blind, single centre, cross-over study on the effects of weekly subcutaneous administration of 40 mg pegvisomant or placebo on quality of life and insulin sensitivit...
Detailed Description
Introduction Both lanreotide (Somatulin Autosolution ™ (SL)) and octreotide (Sandostatin LAR ™ (LAR)) are equally effective in controlling disease activity in acromegalic subjects with a normalization...
Eligibility Criteria
Inclusion
- Active acromegaly.
- Serum total IGF-I levels must have been normalized during long-term treatment with long-acting somatostatin analogs
- Age between 18 and 80
Exclusion
- Any contra-indication for the use of long-acting somatostatin analogs, as e.g. the use of anti-coagulants.
- Subjects with pituitary tumors that compress the optic chiasm
- Patients with insulin dependent diabetes
- Patients with cancer
- Patients with kidney- or liver function disturbances
- Fertile female patients that refuse to take contraceptives during the study
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00642720
Start Date
October 1 2006
End Date
July 1 2007
Last Update
March 25 2008
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